search
Back to results

Exercise Training and Behavioral Modification for the Improvement of Physical Activity in Head and Neck Cancer Patients Undergoing Cancer Treatment

Primary Purpose

Head and Neck Carcinoma, Hypopharyngeal Carcinoma, Laryngeal Carcinoma

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Medical Device Usage and Evaluation
Consultation
Exercise Intervention
Behavioral Intervention
Questionnaire Administration
Quality of Life Assessment
Sponsored by
Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Head and Neck Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosed with head and neck cancer including cancers of the sinuses, oral cavity, oropharynx, hypopharynx, or larynx (all stages); therapeutically eligible to receive at least three months of immunotherapy
  • Medically cleared by oncologist to engage in aerobic and resistance exercise intervention
  • 18 years of age or older
  • Access to a smartphone and have an active wi-fi connection at home
  • Able to read and/or to speak English
  • Able to comprehend and sign a written informed consent (no cognitive decline)
  • Women of reproductive potential must have a negative serum or urine pregnancy test within the week prior to starting therapy

Exclusion Criteria:

  • Severe or unstable cardiopulmonary, metabolic, or renal disease as determined by the referring oncologist
  • Unable to walk safely without physical assistance of another person
  • Any condition that may limit the ability to comply with behavioral recommendations of the program
  • Pregnant or planning a pregnancy

Sites / Locations

  • Thomas Jefferson University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm I (exercise training, behavior modification)

Arm II (Fitbit, consultation)

Arm Description

Beginning 1 week prior to start of intervention, patients receive a Fitbit to monitor physical activity for 13 weeks. Patients receive consultation and personalized exercise prescription from a physical therapist at baseline, and attend exercise training sessions with a physical therapist during weeks 1, 3, 6, 9, and 12. Patients also attend behavior modification sessions with a behavioral therapist that focus on goal setting and healthy behavior changes during weeks 2, 4, 5, 7, 8, 10, and 11.

Patients receive a Fitbit to monitor physical activity for 12 weeks. Patients also receive consultation from a physical therapist to assess physical performance at weeks 1, 6, and 12.

Outcomes

Primary Outcome Measures

Change in Fitbit-recorded average steps (moderate and/or intensive) per day, each day
Changes in physical activity of the intervention group at 6-weeks and 12-weeks, compared to baseline, using two-sample t-tests, respectively. Longitudinal models such as (non)linear mixed models or generalized estimating equation (GEE) models
Change in Fitbit-recorded average steps (moderate and/or intensive) per day, each day
Changes in physical activity of the control group at 6-weeks and 12-weeks, compared to baseline, using two-sample t-tests, respectively. Longitudinal models such as (non)linear mixed models or generalized estimating equation (GEE) models
Change in Fitbit-recorded average active minutes (moderate and/or intensive) per day, each day
time trend will be compared between control and intervention groups at 6-weeks and 12-weeks, compared to baseline, using two-sample t-tests, respectively. Longitudinal models such as (non)linear mixed models or generalized estimating equation (GEE) models

Secondary Outcome Measures

Full Information

First Posted
March 4, 2021
Last Updated
June 8, 2021
Sponsor
Thomas Jefferson University
search

1. Study Identification

Unique Protocol Identification Number
NCT04788264
Brief Title
Exercise Training and Behavioral Modification for the Improvement of Physical Activity in Head and Neck Cancer Patients Undergoing Cancer Treatment
Official Title
A Pilot Study to Assess Feasibility of a Clinically Significant Increase in Physical Activity in Patients With Head and Neck Cancer Undergoing Active Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 28, 2021 (Actual)
Primary Completion Date
March 2022 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thomas Jefferson University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This clinical trial evaluates the tolerability of a physical activity program in head and neck cancer patients who are undergoing cancer treatment. The goal of this trial is to give patients exercises prescribed by a physical therapist that they are able to complete regularly at home. Increasing physical activity may help patients reduce fatigue, improve mood, increase physical performance, and decrease joint pain.
Detailed Description
PRIMARY OBJECTIVE: I. To compare the changes in physical activity between the control and intervention groups of patients with head and neck or lung cancer at 6-weeks and 12-weeks, compared to baseline. SECONDARY OBJECTIVES: I. To demonstrate the feasibility, engagement, retention, and acceptability of physical activity promotion (intervention) in patients with head and neck or lung cancer. II. To calculate the effect sizes for the differences between the control and intervention in daily changes in psychosocial outcomes at 6-weeks and 12-weeks, compared to baseline. EXPLORATORY OBJECTIVE: I. To calculate the effect sizes for the differences between the control and intervention in changes in immunomodulatory, metabolic and aging biomarkers at 6-weeks and 12-weeks, compared to baseline. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Beginning 1 week prior to start of intervention, patients receive a Fitbit to monitor physical activity for 13 weeks. Patients receive consultation and personalized exercise prescription from a physical therapist at baseline, and attend exercise training sessions with a physical therapist during weeks 1, 3, 6, 9, and 12. Patients also attend behavior modification sessions with a behavioral therapist that focus on goal setting and healthy behavior changes during weeks 2, 4, 5, 7, 8, 10, and 11. ARM II: Patients receive a Fitbit to monitor physical activity for 12 weeks. Patients also receive consultation from a physical therapist to assess physical performance at weeks 1, 6, and 12. After completion of study intervention, patients are followed up at 30 days. EXPLORATORY OBJECTIVE: I. To demonstrate the difference in the magnitude of physical activity improvements between the immunotherapy and chemo-immunotherapy patients. OUTLINE: Beginning 1 week prior to start of intervention, patients receive a Fitbit to monitor physical activity for 13 weeks. Patients receive consultation and personalized exercise prescription from a physical therapist at baseline, and attend exercise training sessions with a physical therapist during weeks 1, 3, 6, 9, and 12. Patients also attend behavior modification sessions with a behavioral therapist that focus on goal setting and healthy behavior changes during weeks 2, 4, 5, 7, 8, 10, and 11. After completion of study intervention, patients are followed up at 30 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Carcinoma, Hypopharyngeal Carcinoma, Laryngeal Carcinoma, Maxillary Sinus Carcinoma, Oral Cavity Carcinoma, Oropharyngeal Carcinoma, Paranasal Sinus Carcinoma, Sinonasal Carcinoma, Stage I Laryngeal Cancer AJCC v8, Stage II Laryngeal Cancer AJCC v8, Stage III Laryngeal Cancer AJCC v8, Stage IV Laryngeal Cancer AJCC v8, Stage IVA Laryngeal Cancer AJCC v8, Stage IVB Laryngeal Cancer AJCC v8, Stage IVC Laryngeal Cancer AJCC v8, Lung Carcinoma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I (exercise training, behavior modification)
Arm Type
Experimental
Arm Description
Beginning 1 week prior to start of intervention, patients receive a Fitbit to monitor physical activity for 13 weeks. Patients receive consultation and personalized exercise prescription from a physical therapist at baseline, and attend exercise training sessions with a physical therapist during weeks 1, 3, 6, 9, and 12. Patients also attend behavior modification sessions with a behavioral therapist that focus on goal setting and healthy behavior changes during weeks 2, 4, 5, 7, 8, 10, and 11.
Arm Title
Arm II (Fitbit, consultation)
Arm Type
Active Comparator
Arm Description
Patients receive a Fitbit to monitor physical activity for 12 weeks. Patients also receive consultation from a physical therapist to assess physical performance at weeks 1, 6, and 12.
Intervention Type
Other
Intervention Name(s)
Medical Device Usage and Evaluation
Intervention Description
Receive Fitbit
Intervention Type
Other
Intervention Name(s)
Consultation
Other Intervention Name(s)
Consult
Intervention Description
Receive consultation from a physical therapist
Intervention Type
Other
Intervention Name(s)
Exercise Intervention
Intervention Description
Attend exercise training sessions
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Intervention
Other Intervention Name(s)
Behavior Conditioning Therapy
Intervention Description
Attend sessions with a behavioral therapist
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Change in Fitbit-recorded average steps (moderate and/or intensive) per day, each day
Description
Changes in physical activity of the intervention group at 6-weeks and 12-weeks, compared to baseline, using two-sample t-tests, respectively. Longitudinal models such as (non)linear mixed models or generalized estimating equation (GEE) models
Time Frame
Baseline to 12 weeks after physical activity promotion
Title
Change in Fitbit-recorded average steps (moderate and/or intensive) per day, each day
Description
Changes in physical activity of the control group at 6-weeks and 12-weeks, compared to baseline, using two-sample t-tests, respectively. Longitudinal models such as (non)linear mixed models or generalized estimating equation (GEE) models
Time Frame
Baseline to 12 weeks after physical activity promotion
Title
Change in Fitbit-recorded average active minutes (moderate and/or intensive) per day, each day
Description
time trend will be compared between control and intervention groups at 6-weeks and 12-weeks, compared to baseline, using two-sample t-tests, respectively. Longitudinal models such as (non)linear mixed models or generalized estimating equation (GEE) models
Time Frame
Baseline to 12 weeks after physical activity promotion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with head and neck cancer including cancers of the sinuses, oral cavity, oropharynx, hypopharynx, or larynx (all stages); therapeutically eligible to receive at least three months of immunotherapy Medically cleared by oncologist to engage in aerobic and resistance exercise intervention 18 years of age or older Access to a smartphone and have an active wi-fi connection at home Able to read and/or to speak English Able to comprehend and sign a written informed consent (no cognitive decline) Women of reproductive potential must have a negative serum or urine pregnancy test within the week prior to starting therapy Exclusion Criteria: Severe or unstable cardiopulmonary, metabolic, or renal disease as determined by the referring oncologist Unable to walk safely without physical assistance of another person Any condition that may limit the ability to comply with behavioral recommendations of the program Pregnant or planning a pregnancy
Facility Information:
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grace Lu-Yao, MD
Phone
215-955-8874
Email
Grace.Lu-Yao@jefferson.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Exercise Training and Behavioral Modification for the Improvement of Physical Activity in Head and Neck Cancer Patients Undergoing Cancer Treatment

We'll reach out to this number within 24 hrs